A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
Study Details
Study Description
Brief Summary
This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ryzodeg Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®. |
Drug: Ryzodeg®
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c (Glycosylated Hemoglobin) [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
Percentage point
Secondary Outcome Measures
- Patients with HbA1c less than 7.0 percentage (Yes or No) [At baseline (week 0)]
Percentage of patients
- Patients with HbA1c less than 7.0 percentage (Yes or No) [End of study (week 26)]
Percentage of patients
- Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) [At baseline (week 0)]
Percentage of patients
- Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) [End of study (week 26)]
Percentage of patients
- Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® [Period 1(week-26 to week 0), Period 2(week 0 to week 26)]
Number of events
- Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® [Period 1(week-26 to week 0), Period 2(week 0 to week 26)]
Number of events
- Change in FPG (Fasting Plasma Glucose) [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
mmol/L
- Change in daily total insulin dose [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
Unit/day
- Change in daily basal insulin dose [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
Unit/day
- Change in daily prandial insulin dose [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
Unit/day
- Change in body weight [Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)]
Kg
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
-
Type 2 diabetes mellitus patients
-
Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
-
Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
-
At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
-
Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c [Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation]
-
The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.
Exclusion Criteria:
-
Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
-
Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
-
Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
-
Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
-
Pregnancy patient
-
Patients not treated with the local licensed Ryzodeg®
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Daejeon | Korea, Republic of | 330-721 | |
| 2 | Novo Nordisk Investigational Site | Daejeon | Korea, Republic of | 361-711 | |
| 3 | Novo Nordisk Investigational Site | Seongnam-si | Korea, Republic of | 463-707 | |
| 4 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 03181 | |
| 5 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 06273 | |
| 6 | Novo Nordisk Investigational Site | Suwon-si, Gyeonggi-do | Korea, Republic of | 16247 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical transparency (dept. 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN5401-4653
- U1111-1257-2534